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The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside d...

FDA Device Recall #Z-1939-2024 — Class II — April 18, 2024

Recall Summary

Recall Number Z-1939-2024
Classification Class II — Moderate risk
Date Initiated April 18, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Neurovascular
Location Fremont, CA
Product Type Devices
Quantity 105,286

Product Description

The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.

Reason for Recall

Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.

Lot / Code Information

Catalog/UDI-DI/Lots: M00316310/07613252187158/0000131357, 0000132153, 0000132740, 0000135026, 0000138147, 0000138148, 0000138579, 0000142533, 0000144961, 0000145874, 0000154419, 0000156324, 0000156614, 0000158907, 0000158911, 0000164603, 0000173346, 0000173701, 0000173702, 0000173771, 0000173995; M00316330/07613252187165/0000142692, 0000158995; M00313010/07613252186922/0000129027, 0000129028, 0000129029, 0000129218, 0000129219, 0000129630, 0000129631, 0000129841, 0000129842, 0000129902, 0000130225, 0000130226, 0000130410, 0000130411, 0000130412, 0000130502, 0000130503, 0000130643, 0000130645, 0000130869, 0000130870, 0000131304, 0000131307, 0000131343, 0000131724, 0000131725, 0000131726, 0000132154, 0000132155, 0000132582, 0000132640, 0000132641, 0000133182, 0000133183, 0000133391, 0000133565, 0000133566, 0000133567, 0000133568, 0000133928, 0000133929, 0000134128, 0000134129, 0000134130, 0000134307, 0000134308, 0000135009, 0000135148, 0000135149, 0000135303, 0000135304, 0000135806, 0000135807, 0000136252, 0000136923, 0000137267, 0000137322, 0000137373, 0000137374, 0000137375, 0000138751, 0000139437, 0000141635, 0000142248, 0000142249, 0000142541, 0000142691, 0000143123, 0000143350, 0000143351, 0000143585, 0000143955, 0000144141, 0000144320, 0000144379, 0000144380, 0000144739, 0000144760, 0000144761, 0000144764, 0000144959, 0000144960, 0000145884, 0000145885, 0000146228, 0000146390, 0000146515, 0000146843, 0000146916, 0000147040, 0000147186, 0000147306, 0000147440, 0000147585, 0000147876, 0000148965, 0000149562, 0000150095, 0000150872, 0000150873, 0000151381, 0000151461, 0000151677, 0000151847, 0000151848, 0000152230, 0000152231, 0000152375, 0000152522, 0000152977, 0000153282, 0000153370, 0000153970, 0000154140, 0000154302, 0000154303, 0000154779, 0000154780, 0000154894, 0000154895, 0000155020, 0000155068, 0000156317, 0000156321, 0000156615, 0000156626, 0000156794, 0000156800, 0000157226, 0000157227, 0000157892, 0000157894, 0000158127, 0000158128, 0000158131, 0000158339, 0000158340, 0000159324, 0000159932, 0000159997, 0000159998, 0000160368, 0000160369, 0000160434, 0000160435, 0000160893, 0000160894, 0000160895, 0000161061, 0000161062, 0000161063, 0000162104, 0000162105, 0000162106, 0000162896, 0000162991, 0000162992, 0000163716, 0000163967, 0000163968, 0000164443, 0000164470, 0000165356, 0000165363, 0000165364, 0000166540, 0000166542, 0000166544, 0000170149, 0000170246, 0000170940, 0000171065, 0000171235, 0000172266, 0000172267, 0000172381, 0000172787, 0000172865, 0000172866, 0000173279, 0000174292, 0000174373, 0000174380, 0000174409, 0000174680, 0000174681, 0000175067, 0000175068, 0000175069, 0000175640, 0000175641, 0000175983, 0000175984, 0000175985, 0000175986, 0000176344, 0000176345, 0000176504, 0000176523, 0000176830, 0000176836, 0000177535, 0000178075, 0000178076, 0000178532, 0000178533, 0000178535, 0000178626, 0000179628, 0000179629, 0000180361, 0000180738, 0000180800, 0000193546; M00313020/07613252186939/0000159372, 0000172593; M00313310/07613252186946/0000135007, 0000135008, 0000136409, 0000136410,0000136679, 0000139937, 0000139938, 0000140307, 0000140689, 0000140690, 0000141634, 0000141833, 0000142246, 0000152799, 0000153160, 0000153453, 0000153968, 0000153969, 0000154301, 0000157222, 0000157223, 0000157224, 0000159320, 0000159370, 0000160740, 0000172380, 0000172594, 0000172619, 0000172661, 0000172662, 0000172748, 0000172786, 0000176476, 0000176840, 0000176841, 0000177540, 0000178232, 0000180657, 0000180737, 0000180795; M00313410/07613252186960/0000173997

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Z-1904-2024 Class II Trevo Pro 14 Microcatheter, Catalog: 90231; Tr... Apr 23, 2024
Z-1906-2024 Class II Trevo Trak 21 Microcatheter, Catalog: 90338 Apr 23, 2024
Z-1905-2024 Class II Trevo NXT ProVue 3 x 32, US, Catalog: 90312 ... Apr 23, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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